Post Vaccination Adverse Events in Covid-19 Vaccine Recipients

Vaccine Adverse Reaction Clinical Trial

Official title:

Data Collection for Post Vaccination Adverse Events in Covid-19 Vaccine Recipients in District Bahawalpur A Multi-center Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05254977
• Other study ID #: UCCM/2022/Covid-19/01
• Status: Completed
• Start date: February 26, 2022
• Est. completion date: March 30, 2022

Study information

• Verified date: April 2022
• Source: Islamia University of Bahawalpur
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Covid-19 pandemic is caused by Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-Cov-2) since its outbreak 2019. Protection against Covid-19 can be achieved through global immunization. Various vaccines for SARS-Cov-2 has been registered and approved for administration in humans. It is important to understand the safety and efficacy of vaccines during robust research to develop global immunity against SARS-Cov-2. This study aimed to collect data on post vaccination adverse events in regional population of District Bahawalpur.

Description:

Bahawalpur District of Punjab province has population of 3.998 million and among these 2.6 million above 12 years of age are eligible for vaccination against SARS-Cov-2. 28 centers were established for vaccination within the districts at designated sites for Covid-19 vaccination. 87% targeted population has been vaccinated till 15th February 2022. Investigators designed this study to collect and evaluate data on adverse effects after vaccination of Covid-19. Investigators aimed to collect information through interviewing participants in general places of designated sites of vaccination centers established in District Bahawalpur. History will be recorded from participants and in case of adverse events detailed available history will be recorded including following adverse effects from available records on following. - Cardiovascular adverse effects - Cerebrospinal adverse events - Respiratory disturbances - Hepatobiliary disorders - Urogenital adverse effects - Musculoskeletal adverse effect - Psychological diseases - Blood biomarkers changes - Autoimmune adverse events - Allergic reactions and hypersensitivity Collected data will be summarized to get percentage of adverse effects in general population. Recorded adverse events will be assessed for their frequency in participants and association with vaccination will be assessed through employing statistical methods. Subsequent information on handling of adverse events will be recorded including - Nature of adverse event - Hospitalization and severity of adverse events - Mortality / morbidity caused by vaccination - Days of hospitalization - Changes in Blood biomarkers - Interventions adopted for adverse events - Diseased period - Covid-19 infection positivity through RT-PCR / imaging for round glass opacities / Covid-19 changes Overall efficacy and safety of vaccination will be assessed through collected data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3515
• Est. completion date: March 30, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

Age >12 year Vaccinated (Single Dose, Double Dose, Booster Dose) Clinical diagnosis of Allergic reactions and hypersentivity, Cardiovascular diseases Musculoskeletal diseases Respiratory disease Immunological disease Kidney diseases Exclusion Criteria: Age <12 years of age Not vaccinated History of disease before vaccination -

Related Conditions & MeSH terms

• COVID-19
• Vaccine Adverse Reaction

Intervention

Drug:
• Standard Preparation
Any kind of intervention received to reduce adverse effects

Locations

Country	Name	City	State
Pakistan	University College of Conventional Medicine	Bahawalpur	Punajb

Sponsors (2)

Lead Sponsor	Collaborator
Islamia University of Bahawalpur	District Health Authority (DHA) Bahawalpur District Bahawalpur, Government of Punjab.

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allergic reactions and hypersensitivity	Questionnaire for Allergic reaction at injection site or generalized allergic responses excluding previously known disease	1st January 2021 to 31st December 2021
Primary	Cardiovascular Diseases	Questionnaire for Post Vaccination adverse development of Hypertension, heart diseases, vascular diseases excluding previously known disease	1st January 2021 to 31st December 2021
Primary	Respiratory disorders and Respiratory hypersensitivity	Questionnaire for Cough, dyspnea, Tachypnea, Asthma, Rhinitis, excluding previously known disease	1st January 2021 to 31st December 2021
Primary	Urologic Diseases	Questionnaire for Kidney diseases, Urinary tract infection, Urolithiasis excluding previously known disease	1st January 2021 to 31st December 2021
Primary	Immune system disorders	Questionnaire for Autoimmune diseases, Erythroblastosis, Glomerulonephritis, thrombocytopenia, Autoimmune Lymphoproliferative Syndrome excluding previously known disease	1st January 2021 to 31st December 2021
Primary	Musculoskeletal diseases	Questionnaire for fatigue syndrome, muscle weakness, muscle spasticity, muscle rigidity, Musculoskeletal pain, myalgia, osteoarthritis, Myositis excluding previously known disease	1st January 2021 to 31st December 2021